Ulcerative colitis - Clinical trial details 

Anterior Perineal Plane for Ultra Low Anterior Resection of the Rectum

Recruitment status:
Recruiting
Primary Sponsor:
Queen Mary University of London
Recruitment countries:
United Kingdom
Health condition studied:
Colitis, Ischemic
URL:
Link to the clinical trial website

About the trial

Interventions:
Procedure: APPEAR Procedure
Procedure: Proctectomy
Procedure: Standard abdominal approach for rectal excision
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    - All patients regardless of sex

    - Undergoing surgery (with curative intent) to excise the lower third of the rectum who
    may require a permanent stoma

    - Deemed suitable by multidisciplinary team.

    Exclusion Criteria:

    - Patients under the age of 16

    - Patients in whom sphincter preservation has already been deemed inappropriate for
    medical or surgical reasons (e.g. by an MDT for oncological cure), or in whom surgery
    has been deemed generally inappropriate.
  • Age minimum:  16 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Functional assessment (faecal continence)
Oncological safety assessment - where appropriate
Surgical Safety Assessment
Yield (within each arm of study)
Secondary outcomes:
Target sample size:
30
Study type:
Interventional
Study design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:
  • Name:   Charles H Knowles, PhD FRCS
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Centre for Academic Surgery, Queen Mary University of London
  • Name:   Khalid El-Gendy, BSc MBBS MRCS
  • Address: 
  • Phone:  020 7882 8751
  • Email:  k.el-gendy@qmul.ac.uk
  • Affiliation: 
  • Name:   Khalid El-Gendy, MBBS MRCS
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Centre for Academic Surgery, Queen Mary University of London
  • Name:   Khalid El-Gendy, MBBS MRCS
  • Address: 
  • Phone:  020 7882 8751
  • Email:  k.el-gendy@qmul.ac.uk
  • Affiliation: 
  • Name:   Prof Norman S Williams, MS FRCS
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Centre for Academic Surgery, Queen Mary University of London

Technical details

Scientific title:
A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT00534131
Secondary ID:
09/H0704/30
Register:
ClinicalTrials.gov
Date of registration:
21/09/2007
Date of first enrollment:
April 2004
Last refreshed:
17 October 2012

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